NASHUA, N.H. July 27, 2011
ISO 13485:2003 is an internationally recognized accreditation that establishes protocols to assure the safety, quality and performance of medical devices – including components such as the PCBs that are at the heart of devices ranging from pacemakers to MRI machines.
Paul Boduch (http://www.massdesign.com)
ISO 13485:2003 specifies a quality management system and record-keeping standards needed to meet customer and regulatory requirements applicable to the manufacture medical devices and components. The recent certification is in addition to the quality processes and standards Mass Design adopted under the broader and more widely recognized ISO 9001:2008 manufacturing standard.
"Our people are to be commended for developing the internal audit system, spot check mechanisms, and communication protocols needed to meet ISO 13485 standards. The new medical certification adds value to our printed circuit board products and the Mass Design brand and serves to increase customer confidence globally," added Boduch.
Moreover, Mass Design has been leading the way with flexible circuit board technology that allows medical device manufacturers to cram more functionality into smaller spaces while enhancing reliability. Flexible circuit boards integrate circuitry and wiring into a single unit that can conform to just about any shape. For example, Mass Design produces flexible circuit boards for prosthetic limb manufacturers.
"ISO 13485 will play a key role in our sales growth, which increased 18% this year in the medical electronics sector – diagnostic and monitoring equipment, surgical tools and both implantable and non-implantable medical devices," said Bill Gately, Mass Design’s sales manager.
Mass Design fabricates printed circuit boards (PCBs) for original equipment manufacturers as well as manufacturing fully assembled printed circuit boards with all components installed.
SOURCE Mass Design Incorporated